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Tuesday, June 6, 2017

NSAID BLACK BOX WARNING

© MMXVII V.1.0.2
by Morley Evans



June 6, 2017, Regina

WHAT COULD BE SAFER than the pain reliever in your medicine cabinet? The Food and Drug Authority has strengthened the current warnings about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Aspirin, Ibuprofen and Naproxen

WebMD says: 

NSAIDs — or non-steroidal anti-inflammatory drugs — are among the most common pain relief medicines in the world. Every day more than 30 million Americans use them to soothe headaches, sprains, arthritis symptoms, and other daily discomforts, according to the American Gastroenterological Association. And as if that wasn't enough, in addition to dulling pain NSAIDs also lower fever and reduce swelling.

The FDA says:

The labels for both prescription NSAIDs and OTC NSAIDs already have information on heart attack and stroke risk. In the coming months, FDA will require manufacturers of prescription NSAIDs to update their labels with more specific information about heart attack and stroke risks. FDA will also request that the manufacturers of OTC NSAIDs update the heart attack and stroke risk information in Drug Facts labels.

FDA added a boxed warning to prescription drug labels for this risk in 2005. More recent data and information are prompting FDA to update NSAID labelling. Today we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks.

“There is no period of use shown to be without risk,” says Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.

People who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for cardiovascular adverse events associated with NSAIDs.

FDA is adding information in the drug label for people who already have had a heart attack. This vulnerable population is at an increased risk of having another heart attack or dying of heart attack-related causes if they’re treated with NSAIDs, according to studies.

But the risk is also present in people without cardiovascular disease. “Everyone may be at risk – even people without an underlying risk for cardiovascular disease,” Racoosin adds.


That should be clear enough.


READ MORE FROM THE FDA

Along with the century-old known risk of bleeding ulcers and death caused by Aspirin, doctors and TV ads prescribe Aspirin for preventing secondary heart attack and as post heart surgery "therapy", believe it or not. Surgeons perform cardiac by-pass surgery and install stents despite knowing these do not extend life. Why would they do that? The American Gastroenterological Association cited above by WebMD is interested in NSAIDs because they cause bleeding ulcers and death which, by the way, killed a doctor I knew! It took her a long time to die. Nothing that was done, month after month, could save her. But no one learned a lesson from this, not even her family, her (late) husband and two of her sons, who were and are all doctors. Amazing, isn't it?


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